High-quality recombinant SARS-CoV-2 antigens and antibodies are key reagents in the development of SARS-CoV-2 serological test kits. ACROBiosystems has developed a series of SARS-CoV-2 antigen and antibody products that can be used in serological tests. 

Sepsis remains a significant cause of morbidity and mortality in hospitalized patients. Cancer patients and other immunocompromised hosts are particularly at increased risk of sepsis. Novel molecular methods for rapid diagnosis directly from blood samples are now available for identification of pathogens and select resistance markers. This presentation will review the clinical impact of rapid molecular tests on patient outcomes at a tertiary cancer care center.

The Department of Defense, Chemical and Biological Technologies Department is managing a disruptive portfolio developing algorithms utilizing artificial intelligence approaches to deliver warning of an acute exposure to a pathogen or toxic chemical prior to overt signs and symptoms using non-invasive biomarkers. The portfolio has shown successes in both animal and human exposure studies, and will continue to pursue advancing the research to provide early identification of exposure.

Healthcare is transitioning from a fee-for-service model to one focused on value-based care. As a key component of patient care and the value-based equation, clinical laboratories will need to be an active participant in the development of diagnostic stewardship programs, so that healthcare providers are guided towards the “right test, for the right patient, at the right time.” This presentation will provide an overview of establishing an effective diagnostic stewardship program, and provide examples of how healthcare providers can be guided towards appropriate testing and result interpretation. Specific case scenarios will be reviewed to demonstrate how diagnostic stewardship can lead to increased efficiency, reduced cost, and improved patient care.

GeneChip Resequencing microarrays have been advanced for infectious disease agent detection and identification from Ebola to Zika. Next-generation sequencing with the highly mobile and cost-effective nanopore sequencing device is challenging the supremacy of the microarray in rapid point-of-need pathogen detection. This talk will present results of side-by-side application of these two platforms for detection in pathogen-spiked blood samples and compare their performance.

As part of the Multiplex Panel session, this talk will focus on multiplex testing for the laboratory diagnosis of meningitis and encephalitis as compared to standard-of-care testing. The potential benefits and limitations of panel testing for meningitis and encephalitis compared to standard-of-care testing will be discussed. The potential approaches to maximize testing yield will also be discussed.

The BioFire FilmArray Pneumonia Panel (PP) detects 15 common bacterial pathogens semi-quantitatively (copy # from 104 to 107), 3 atypical pneumonia bacteria, 8 viruses, and 7 antimicrobial resistance markers by multiplex PCR in about 1 hour in the laboratory. Results of our 396-patient study suggest PP detects more bacterial isolates than conventional microbiology, and the copy number correlates with outcome variables, such as ICU length of stay, temperature, and white cells in the BAL. Results reported in a 3-4 h timeframe after a BAL could potentially improve both antibiotic choice and de-escalation in critically ill intubated patients.

This talk will focus on the reimbursement challenges under PAMA for the more commonly performed diagnostic tests. The talk will focus primarily on coding and payment issues, and will provide policy updates.

Even though the global threat of antibiotic-resistant microorganisms is significant, many patients demand antibiotics and doctors are far too willing to provide them. This talk shows that the relationship between us and our bacteria is more important than previously thought. Disrupting that balance can cause a host of medical issues.

Karius microbial cell-free DNA sequencing from plasma (mcfDNA-Seq) is emerging as an alternative to invasive diagnostic tests for species-level identification of pathogens.  We will present consolidated results from several clinical studies to address key questions on how to use this new technology to improve patient outcomes and lower diagnostic testing costs in immunocompromised patients with suspected invasive infection.

Antigens and antibodies are key components for serological diagnosis kits. Sino Biological used mammalian cells for antigen production to ensure proper biological activity. Antibodies against viral proteins were generated by multiple platforms, including hybridoma, phage display and B cell cloning, to achieve high sensitivity and specificity.

Metagenomic next-generation sequencing (mNGS) is a transformative technology for infectious disease diagnosis as it enables detection of nearly all pathogens – viruses, bacteria, fungi, and parasites – in a single assay. Here we will discuss the integration of multiple approaches to enhance the clinical utility of body fluid mNGS, including nanopore sequencing, CRISPR-Cas12-based pathogen detection, complementary host response analyses, and simultaneous diagnosis of cancer.

Initial efforts for applying metagenomic next-generation sequencing (mNGS) for infectious disease diagnostics have focused on pathogen detection. However, we can also gain information on antimicrobial resistance markers, virulence factors or even host biomarkers associated with different disease states. In this presentation, we will discuss the challenges of using mNGS for detection of antimicrobial resistance genes to predict phenotypes and discuss the current status of mNGS for detection of antimicrobial resistance.